Company Expects to Initiate Phase 1/2 Trial of NT-219 as Monotherapy Treatment of Advanced Solid Tumors and in Combination with cetuximab for Treatment of Recurrent or Metastatic Solid Tumors and Head and Neck CancerTEL AVIV, Israel, May 19, 2020 (GLOBE NEWSWIRE) — Kitov Pharma Ltd. (“Kitov”) (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, today announced that preclinical data for NT219, a novel agent addressing treatment resistance in advanced cancer, will be presented in a poster at the American Association of Cancer Research (AACR) Virtual Meeting II.The presentation, titled, “NT219, a novel dual inhibitor of STAT3 and IRS1/2, demonstrates anti-tumor activity with and without cetuximab in pembrolizumab-resistant head and neck cancer PDX models,” includes preclinical data on NT219, a first-in-class, dual inhibitor of signal transducer and activator of transcription 3 (STAT3) and insulin receptor substrate 1 and 2 (IRS1/2), which have been associated with treatment resistance in a variety of cancer settings. Using multiple patient derived xenograft (PDX) models of subjects with head and neck squamous cell carcinoma (HNSCC), NT219 demonstrated growth inhibition, both as monotherapy (3/6 mice), as well as in combination with cetuximab, an epidermal growth factor receptor (EGFR) inhibitor, or pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor (5/6 mice). Notably, in one study of a PDX model of a recurrent/metastatic HNSCC sample that was resistant to radiation, various chemotherapies and pembrolizumab, utilizing NT219 alone resulted in tumor growth inhibition (TGI) of 69% (p=0.017).  Moreover, while cetuximab alone was not effective (TGI=17%), the combination of cetuximab with NT219 showed synergistic effect and induced regression of all tumors (p=0.001).   “These encouraging preclinical data strongly suggest that the inhibition of the STAT3 and IRS-AKT pathways has the potential to address the tumor resistance phenotype,” said Isaac Israel, Chief Executive Officer of Kitov. “Based on the significant compelling preclinical evidence generated in various studies with NT219, including these data, our planned Phase 1/2 trial of NT219 will evaluate our promising product candidate both as a monotherapy treatment in patients with advanced solid tumors and in combination with cetuximab in patients with HNSCC.  We look forward to initiating this Phase 1/2 trial soon.”Presentation Details:
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